CHICAGO — A phase 3 noninferiority study has found that in patients with nonoperable locally advanced squamous cell cancer of the head and neck, concurrent chemoradiotherapy remains the standard treatment, according to results presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting.1
The GORTEC 2007-02 study failed to demonstrate any superiority of the induction regimen of docetaxel, cisplatin, and 5-fluorouracil (5-FU) followed by cetuximab with radiotherapy for the end points of progression-free survival, overall survival, or locoregional control, said Lionnel Geoffrois, MD, Centre Alexis Vautrin, Vandoeuvre-Lès-Nancy, France, on behalf of the GORTEC group.
The study’s goal was to determine if induction therapy followed by radiation therapy plus cetuximab improved progression-free survival at 2 years, the primary end point. To detect a hazard ratio (HR) of 0.66, 370 patients needed to be included to achieve 80% power at 2-sided significance level of 0.05, he said.
The trial was restricted to patients with cervical nodes N2b (clinically palpable), N2c, or N3 and was conducted in parallel with the GORTEC 2007-01 study, which was testing the addition of concurrent chemotherapy to cetuximab-radiotherapy in patients with N0-N2a disease.
Between May 2009 and August 2013, 370 patients with nonmetastatic, nonoperable stage III-IV squamous cell carcinoma of the oral cavity, oro/hypopharynx and larynx, regardless of HPV status, were randomly assigned to receive concurrent carboplatin and 5-FU plus radiotherapy (n = 184) or induction docetaxel, platinum, and 5-fluorouracil plus cetuximab-radiotherapy (n = 186).
Radiotherapy was administered at 70 Gy (2 Gy per day, 5 days per week). Concurrent chemotherapy comprised 3 cycles of carboplatin 70 mg/m²/day + 5-FU 600 mg/m²/day on days 1 to 4.
At a median follow-up of 31.2 months, no difference was observed in median progression-free survival between the concurrent chemoradiotherapy and induction followed by cetuximab-radiotherapy arms (HR, 0.93; 95% CI, 0.73-1.20; P = .58], nor was there a difference in median overall survival (HR, 1.12; 95% CI, 0.86-1.46; P = 0.39).
The trial also failed to show an improvement in locoregional control; however, there was a significant delay in distant metastases as a first event in the cetuximab-radiotherapy arm (HR 0.54; 95% CI, 0.30-.0.99; P = .05).
1. Geoffrois L, Martin L, Garaud P, et al. Induction docetaxel platinum 5-FU (TPF) followed by cetuximab-radiotherapy (cetux-RT) versus concurrent chemo-radiotherapy (CT/RT) in patients with N2b/c-N3 non operated stage III-IV squamous cell cancer of the head and neck (SCCHN): Results of the GORTEC 2007-02 phase III randomized trial. Oral presentation at: 2016 ASCO Annual Meeting; June 3-7, 2016; Chicago, IL.